FDA product code GNN: Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6

GNN is the FDA product code for antisera, neutralization, coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GNN. The average 510(k) review took 28 days (median 28).

Classification

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Recalls for GNN devices

openFDA lists no recalls for product code GNN.

Frequently asked questions

What is FDA product code GNN?

GNN is the FDA product code for antisera, neutralization, coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel.

What device class is GNN?

Class I, regulation 21 CFR 866.3145. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code GNN?

Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).

Which companies have the most GNN clearances?

Kelleher Corp. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code GNN
• Run a recall and safety report across every GNN manufacturer
• Watch product code GNN for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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